FDA Cautions Against the Hazards of Compounded Ketamine

 

FDA Cautions Against the Hazards of Compounded Ketamine

The U.S. Food and Drug Administration (FDA) Issues Warning About Compounded Ketamine: Risks and Concerns for Mental Health Patients

The U.S. Food and Drug Administration (FDA) has issued a vital warning to consumers regarding the use of compounded versions of the medication ketamine, frequently utilized for psychiatric disorders. This caution comes as compounded products present unique and potentially severe risks to individuals seeking alternative treatments for their mental health.

Compounded products, in this context, refer to medications that are not subject to the FDA's rigorous evaluation process for safety and effectiveness, unlike approved drugs. Therefore, they exist in a regulatory gray area, making their usage inherently riskier.

While acknowledging that compounded drugs may fill a crucial medical need for specific patients when FDA-approved alternatives are unsuitable, the FDA strongly emphasizes the importance of supervised medical guidance. Compounded medications, including ketamine, should only be used under the supervision of a healthcare provider, warns the FDA in a recent news release.

A compelling case that underscores these concerns came to light in April, in which a patient self-administered compounded oral ketamine to treat post-traumatic stress disorder (PTSD). Tragically, this resulted in slowed breathing and significantly elevated ketamine blood levels, almost double the amount typically administered as anesthesia.

Interest in compounded ketamine products, including oral formulations, for the treatment of various mental health disorders such as depression, anxiety, PTSD, and obsessive-compulsive disorder, is on the rise, according to the FDA.

It is important to note that ketamine, especially when used outside of a clinical setting, is associated with a range of safety concerns, including abuse, misuse, psychiatric side effects, elevated blood pressure, slowed breathing, and lower urinary tract and bladder symptoms.

In contrast, the FDA-approved ketamine product offers therapeutic benefits that outweigh these risks when administered at appropriate doses. Despite the growing appeal of compounded ketamine, there is no concrete evidence to suggest that it is safer, more effective, or faster-acting than FDA-approved medications for specific psychiatric disorders, states the FDA.

Ketamine hydrochloride is classified as a controlled substance. It is an FDA-approved medication typically administered intravenously or intramuscularly as part of general anesthesia. It contains two mirror-image molecules, arketamine and esketamine. Another FDA-approved medication, Spravato, contains only one of these molecules and is available as a nasal spray for adults with treatment-resistant depression or depressive symptoms accompanied by acute suicidal ideation or behavior. This nasal spray is intended to be used alongside an oral antidepressant.

It's worth noting that the FDA had previously issued a warning about the use of compounded ketamine nasal spray early last year. This warning also extended to Spravato, which has a Risk Evaluation and Mitigation Strategy (REMS) as part of its FDA approval. A REMS is a drug safety program instituted by the FDA for certain approved medications with significant safety concerns, intended to ensure that the benefits of the medication outweigh the risks.

The Spravato REMS necessitates the administration of esketamine in medically supervised healthcare settings certified under the program. These settings are required to monitor patients for at least two hours to observe potential sedation, out-of-body sensations (dissociation), and the risk of misuse and abuse.

The FDA acknowledges that obtaining compounded products through telemedicine platforms and using them at home may seem appealing to certain patients. However, the FDA strongly reiterates the associated risks of such an approach. Administering these products at home is particularly perilous due to the absence of monitoring for adverse effects.

Key vital signs, including blood pressure and heart rate, as well as indicators of sleepiness, dissociation (a state of disconnection between thoughts, feelings, and one's sense of time, space, and self), remain unmonitored when compounded products are used outside of healthcare settings. Additionally, essential information about these compounded products, such as proper dosing, remains woefully inadequate, according to the FDA.

The FDA encourages compounders, patients, and healthcare providers to report any adverse events or issues associated with these products to the FDA's MedWatch Adverse Event Reporting Program, underlining their commitment to public safety.